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- W2394050100 abstract "OBJECTIVE To evaluate the pharmacokinetics(PK) and pharmacodynamics of subcutaneous injection of rh-insulin by euglycemic clamp technique in healthy volunteers.METHODS This was a mono-centre,randomized,double blinded two periods,cross-over open-label comparative study in 22 healthy volunteers,who were randomly received the rh-insulin or regular insulin subcutaneous administration.All subjects underwent an oral glucose tolerance test,an evaluation of their metabolic profiles and a 10 h euglycaemic hyperinsulinaemic clamp test.The blood samples of the clamp study at-120,-90,-60,-30,0,10,20,30,40,50,60,70,80,90,100,110,120,150,180,210,240,270,300,330,360,390,420,450,480 min were taken for insulin detection,meanwhile,glucose infusion rate(GIR) were determined per 10 min over the first 2 h and per 15 min over the next period of 6 h.RESULTS During the euglycaemic hyperinsulinaemic clamp,whole-body glucose use and C-peptide suppression were similar in the two treatment groups at baseline,and the Cmax of insulin were of tested and reference preparation were 108.64±18.98,111.92±118.02 mU·L-1,Tmax were 78.00±31.56,86.00±38.44 min,AUC0～480 were 20.6801±5.5153,21.3471±5.4641 U·L-1,GIRmax were 5.55±1.73,6.16±1.69 mg·kg-1·min-1,respectively.CONCLUSION Euglycemic-hyperinsulinemic clamp technique is use for the research of insulin pharmacotinetics and pharmacodynamics.The study shows that there were no significant differences of the pharmacokinetic and pharmacodynamic properties between the rh-insulin and regular insulin,the tested rh-insulin and reference preparation are bioequivalent." @default.
- W2394050100 created "2016-06-24" @default.
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- W2394050100 date "2011-01-01" @default.
- W2394050100 modified "2023-09-23" @default.
- W2394050100 title "Investigation on pharmacokinetics and pharmacodynamics of rh-insulin in healthy volunteers" @default.
- W2394050100 hasPublicationYear "2011" @default.
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